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Effect of Adding Progressive Muscle Relaxation to Physical Therapy Program on Fatigue, Mobility and Stress Among Individuals With Traumatic Lower Limb Amputation in the Gaza Strip

Effect of Adding Progressive Muscle Relaxation to Physical Therapy Program on Fatigue, Mobility and Stress Among Traumatic Lower Limb Amputees in Gaza Strip

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07139145
Acronym
PMR-AMP
Enrollment
60
Registered
2025-08-24
Start date
2025-09-15
Completion date
2026-02-26
Last updated
2025-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fatigue, Mobility Impairment, Psychological Stress, Traumatic Lower Limb Amputation

Keywords

Progressive Muscle Relaxation (PMR), Physiotherapy, Rehabilitation, Fatigue, Mobility, Stress, Weight-Bearing Symmetry, Gaza Strip, Amputees, Randomized Controlled Trial (RCT)

Brief summary

Lower limb amputation is a life-altering condition with profound physical and psychological consequences, including fatigue, impaired mobility, stress, and asymmetrical weight-bearing. These challenges are particularly severe in conflict-affected settings like the Gaza Strip, where access to rehabilitation services is limited. This study aims to evaluates the effect of adding Progressive Muscle Relaxation (PMR), a simple and cost-effective relaxation technique, to standard physical therapy on Fatigue, mobility, weightbearing distribution and stress outcomes among adults with unilateral traumatic lower limb amputation in Gaza. Study design: RCT with 60 participants will be randomly assigned to either (1) a control group receiving standard physiotherapy or (2) an intervention group receiving standard physiotherapy plus PMR. Outcomes will be measured using validated instruments: Fatigue Severity Scale (FSS), 2-Minute Walk Test (2MWT), Perceived Stress Scale (PSS-10), and dual bathroom scale method for weight-bearing distribution. Assessments will be conducted at baseline, post-intervention (6 weeks), and follow-up (8 weeks). The study aims to determine whether integrating PMR into rehabilitation improves fatigue reduction, functional mobility, stress management, and weight-bearing symmetry compared to physiotherapy alone. Findings will contribute to evidence-based rehabilitation strategies for amputees in low-resource, high-stress environments.

Detailed description

This study protocol addresses the multidimensional challenges faced by individuals with traumatic lower limb amputation in the Gaza Strip, a conflict-affected region with limited access to rehabilitation. Amputees often experience persistent fatigue, impaired mobility, asymmetrical weight-bearing, and high psychological distress. Standard physical therapy primarily focuses on physical recovery, while psychosocial rehabilitation is often overlooked. Rationale: Progressive Muscle Relaxation (PMR) is a structured mind-body technique that systematically tenses and relaxes muscle groups to reduce stress and physical tension. Evidence from other populations, including patients with cancer, chronic illnesses, and stroke, has shown PMR to be effective in reducing fatigue, anxiety, stress, and improving functional performance. However, its use in amputee rehabilitation-particularly in conflict settings-remains underexplored. Study Objectives: General Objective: To evaluate the effect of integrating PMR with physiotherapy program on Fatigue, mobility, weightbearing distribution and stress among individuals with traumatic lower limb amputation. Study Design: Randomized controlled trial (RCT) with 60 participants allocated to intervention (PMR + physiotherapy) or control (physiotherapy alone) groups using block randomization and concealed allocation. Outcome Measures: Fatigue (FSS), mobility (2MWT), Stress (PSS-10), weight-bearing symmetry (dual scale method). Assessment Timeline: Baseline (week 0), post-intervention (week 6), and follow-up (week 8). Sample Size: 60 participants (30 per group), based on power analysis accounting for attrition. Data Analysis: Descriptive statistics, paired t-tests, independent t-tests, and repeated-measures ANOVA. Intention-to-treat analysis will be applied. Ethics: Approval is obtained from the Helsinki Committee and the Artificial Limbs and Polio Center (ALPC). Informed consent will be secured, confidentiality maintained, and adverse events monitored. Expected Impact: This study will provide the first randomized evidence on the effectiveness of PMR in traumatic amputee rehabilitation within Gaza. It is expected that adding PMR to physiotherapy will significantly reduce fatigue and stress, improve mobility, and enhance weight-bearing symmetry compared to physiotherapy alone. Results will inform rehabilitation protocols in low-resource, conflict-affected settings and may guide future policy and practice for amputee care.

Interventions

BEHAVIORALProgressive Muscle Relaxation + Standard Physiotherapy

Standard physiotherapy exercises plus PMR sessions. PMR is gradually transitioned from therapist-guided to self-directed practice across the 6 weeks.

BEHAVIORALStandard Physiotherapy

Participants receive a 6-week standard physiotherapy program delivered twice weekly. Sessions include warm-up, weight-bearing training, balance exercises, gait training, and functional activities. The protocol focuses on improving mobility, weight-bearing capacity, balance, and functional independence. No Progressive Muscle Relaxation or additional behavioral techniques are included.

Sponsors

Marah Radi
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Intervention model description

Participants will be randomly allocated in a 1:1 ratio to either an intervention group (standard physiotherapy plus Progressive Muscle Relaxation) or a control group (standard physiotherapy alone). The trial will follow a parallel-group design, with outcomes assessed at baseline, post-intervention (6 weeks), and follow-up (8 weeks).

Eligibility

Sex/Gender
ALL
Age
18 Years to 59 Years
Healthy volunteers
No

Inclusion criteria

* Adults aged 18 to 59 years. * Unilateral traumatic trans-femoral/transtibial amputation. * Post prosthetic fitting.

Exclusion criteria

* Severe comorbidities (e.g., uncontrolled cardiovascular disease). * Severe cognitive impairment or mental illness. * Recent orthopaedic surgery (\<3 months)

Design outcomes

Primary

MeasureTime frameDescription
Fatigue LevelBaseline, 6 weeks post-intervention and 8 weeks follow upAssessed using the Fatigue Scale-2, measuring perceived physical and mental fatigue. Scores quantify fatigue severity.
MobilityBaseline, 6 weeks post-intervention and 8 weeks Follow upMeasured using the 2-Minute Walk Test (2MWT) to assess distance walked in meters.
Stress LevelBaseline, 6 weeks post-intervention and 8 weeks followingAssessed with a validated Perceived Stress Scale measuring psychological stress
Weight-Bearing distributionBaseline, 6 weeks post-intervention and 8 weeks followingMeasured using a dual bathroom scale during standing tasks to assess weight-bearing capacity.

Countries

Palestinian Territories

Contacts

Primary ContactMarah Nayef Radi, MSc
m.radi@hi.org+972597235445
Backup ContactMosab Aldabbas, PhD
mosab.m.aldabbas@gmail.com+972562563022

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026